The study will assess the relative bioavailability and bioefficacy of cryptoxanthin (CX) and beta-carotene (BC) from food sources for increasing breast milk carotenoid and retinol concentrations in lactating Bangladeshi women.

Impact of Daily Feeding of Food Sources of Cryptoxanthin (CX) and Beta-carotene (BC) on Plasma and Breast Milk Concentrations of CX, BC, and Retinol (VA) in Lactating Women With Marginal Vitamin A Status

The specific aim is to compare the effects of orange-fleshed sweet potatoes and tangerines compared to white-fleshed sweet potatoes and vitamin A as retinyl palmitate on blood and breast milk cryptoxanthin (CX), beta-carotene (BC), and vitamin A (VA) concentrations by randomly assigning lactating Bangladeshi women to one of four treatment groups for 6 days/week for 3 weeks.

The investigators will also compare the relative vitamin A (VA) value of BC and CX from food sources by comparing the mean change in breast milk retinol concentrations of the groups that receive tangerines (CX) or orange-fleshed sweet potatoes (BC) with the mean change in breast milk retinol of the group that receives retinyl palmitate.

Eligibility

Ages Eligible for Study:

18 Years to 45 Years (Adult)

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Healthy women in Dhaka, Bangladesh

Lactating women in their 2nd or 3rd month of lactation who are planning to breast-feed at least 6 months

Breast-feeding only one infant

Age range 18 to 45 years

Not pregnant

Serum retinol concentrations >0.70 umol/L and <1.10 umol/L

Normal concentrations of CRP (<10 mg/L)

At least one arm vein deemed adequate for blood collection, as evaluated by a screening nurse.

Willing to consume the test foods daily 6 d/wk for one month

Exclusion Criteria:

Health status is not compatible with the inclusion criteria, such as screening blood chemistries indicative of vitamin A deficiency.

Severe anemia (Hb <9 mg/dL)

Current pregnancy

Must not have known allergy to citrus fruit (tangerines or mandarin oranges) or sweet potatoes

Must have no obvious psychological or sociological problems—such as alcoholism, drug abuse, or severe and acute mental illness that would influence their ability to sign an inform consent agreement or to participate in study duties and activities

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420406